WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pristiq or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pristiq is not approved for use in pediatric patients [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 ), and Patient Counseling Information ( 17.1 ) ].
Pristiq is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O‑desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.
Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (14) and Dosage and Administration (2.1) ]. The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
Media Articles Related to Pristiq (Desvenlafaxine)
Double Trouble: Depression Plus Diabetes Boosts Dementia Risk
Source: Medscape Psychiatry & Mental Health Headlines [2015.04.16]
Depression and diabetes raise the risk for dementia. Together they post the greatest risk, particularly in individuals younger than 65 years.
Medscape Medical News
Depression and diabetes combined may create even higher risk of cognitive decline
Source: Depression News From Medical News Today [2015.04.16]
Depression and diabetes each raised dementia risk on their own, but risk rose even more for people with both, in a large study of Alzheimer's disease and vascular dementia.
Depression Plus Diabetes May Boost Dementia Risk
Source: MedicineNet Dementia Specialty [2015.04.16]
Title: Depression Plus Diabetes May Boost Dementia Risk
Category: Health News
Created: 4/15/2015 12:00:00 AM
Last Editorial Review: 4/16/2015 12:00:00 AM
Antidepressant Washout Safe in Resistant Depression
Source: Medscape Psychiatry & Mental Health Headlines [2015.04.15]
Taking patients with treatment-resistant depression off antidepressant medication for a period in order to initiate a new antidepressant agent appears to be safe.
Medscape Medical News
Depression, Insomnia, Fatigue Are the Stuff of Nightmares
Source: MedicineNet Depression Specialty [2015.04.15]
Title: Depression, Insomnia, Fatigue Are the Stuff of Nightmares
Category: Health News
Created: 4/14/2015 12:00:00 AM
Last Editorial Review: 4/15/2015 12:00:00 AM
Published Studies Related to Pristiq (Desvenlafaxine)
Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled
study of perimenopausal and postmenopausal women with major depressive disorder. 
CONCLUSIONS: Short-term treatment with desvenlafaxine 50 mg/d was effective for
Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year
in women with vasomotor symptoms associated with menopause. 
population followed for 1 year... CONCLUSIONS: There is no evidence for an increased risk of cardiovascular,
Desvenlafaxine compared with placebo for treatment of menopausal vasomotor
symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind,
placebo-controlled efficacy trial. 
moderate to severe hot flashes per week... CONCLUSIONS: Postmenopausal women with moderate to severe hot flashes who are
Randomized placebo- and active-controlled study of desvenlafaxine for menopausal vasomotor symptoms. [2011.11.08]
ABSTRACT Objective To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs... Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo.
Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. [2011.03.01]
BACKGROUND: Preliminary clinical evidence indicates that menopausal status might impact on the efficacy of certain classes of antidepressants. OBJECTIVE: The aim of this study was to evaluate open-label desvenlafaxine treatment (administered as desvenlafaxine succinate) in postmenopausal women who did not achieve clinical response to acute, double-blind treatment with desvenlafaxine or escitalopram... CONCLUSIONS: Postmenopausal women with major depressive disorder who did not respond to acute, double-blind treatment with escitalopram or desvenlafaxine achieved modest, continued improvement with long-term, open-label desvenlafaxine therapy. Further interpretation of these findings is limited by aspects of the study design (i.e. open-label, non-placebo-controlled) and the lack of randomized comparison groups in the extension phase, which prevents statistical assessment of the efficacy of longer term treatment with desvenlafaxine. Clinicaltrials.gov identifier: NCT00406640.
Clinical Trials Related to Pristiq (Desvenlafaxine)
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder [Recruiting]
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet [Recruiting]
To evaluate the pharmacokinetics and safety of single dose and multiple doses of
desvenlafaxine in Korean healthy subjects and compare to westerners.
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients [Recruiting]
This is a non-interventional study to review safety data on administration of desvenlafaxine
succinate among Filipino patients with MDD and VMS per usual clinical practice within the
first three years post commercial distribution.
Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR) [Recruiting]
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD) [Recruiting]
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of
desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with
major depressive disorder.
Reports of Suspected Pristiq (Desvenlafaxine) Side Effects
Drug Ineffective (223),
Feeling Abnormal (158),
Withdrawal Syndrome (117), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 11 ratings/reviews, Pristiq has an overall score of 7.27. The effectiveness score is 7.82 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Pristiq review by 52 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Depression|
|Dosage & duration:|| || 50mg taken once daily for the period of I have been taking this drug for 6 month|
|Other conditions:|| || anxiety|
|Other drugs taken:|| || xanax|
|Benefits:|| || This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned.|
|Side effects:|| || Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks.|
|Comments:|| || I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well.|
Pristiq review by 47 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || depression|
|Dosage & duration:|| || 40 mg taken once daily for the period of two years|
|Other conditions:|| || ADHD|
|Other drugs taken:|| || Vyvanse|
|Benefits:|| || Pristiq elevated mood and energy levels. |
|Side effects:|| || Increased anxiety|
|Comments:|| || Pristiq was prescribed at a 20 mg dose and then increased to 40 mg dose. I continue to take it as it has been the most effective medication for alleviating symptoms of depression that I have tried, including Prozac, Effexor, Wellbutrin and Lexapro.|
Pristiq review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || severe depression|
|Dosage & duration:|| || 50mg taken 50 mg once daily for the period of little more than 2 weeks|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I had no benefits|
|Side effects:|| || Nausea, dizziness, increased anxiety, and extreme irritibility.|
|Comments:|| || I could not control my irritability. It was out of control. I felt like I was not myself. When starting my third week on this med, I stopped. By day two I felt much better. Would not try this drug again. Had only slight nausea after stopping this medications that quickly went away. My depression worsened on this med. Would not recommend.|
Page last updated: 2015-04-16